Cleared Traditional

TiLink-L SI Joint Fusion System

K230446 · SurGenTec, LLC · Orthopedic
Jun 2023
Decision
106d
Days
Class 2
Risk

About This 510(k) Submission

K230446 is an FDA 510(k) clearance for the TiLink-L SI Joint Fusion System, a Sacroiliac Joint Fixation (Class II — Special Controls, product code OUR), submitted by SurGenTec, LLC (Boca Raton, US). The FDA issued a Cleared decision on June 7, 2023, 106 days after receiving the submission on February 21, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K230446 FDA.gov
FDA Decision Cleared SESE
Date Received February 21, 2023
Decision Date June 07, 2023
Days to Decision 106 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code OUR — Sacroiliac Joint Fixation
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3040
Definition Sacroiliac Joint Fusion